Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls
FDA 510(k) K023763 · Randox Laboratories, Ltd.
510(k) numberK023763
Submission
- Device name
- Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, GB - Received
- November 8, 2002
- Decision date
- January 13, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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Questions and answers
When was Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls cleared by the FDA?
Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls (K023763) received a 510(k) decision of Substantially Equivalent on January 13, 2003, 66 days after the submission was received.
What is the product code of K023763?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.